Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000870752
Ethics application status
Approved
Date submitted
31/07/2013
Date registered
6/08/2013
Date last updated
7/08/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effectiveness Of A Brief Physician Counselling Session In Improving Smoking Behaviour At Workplace.
Scientific title
In a population of smokers at a factory, would brief physician counseling improve the stages of smoking cessation?
Secondary ID [1] 282895 0
NIL
Universal Trial Number (UTN)
U1111-1146-2045
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking 289712 0
Condition category
Condition code
Public Health 290033 290033 0 0
Health promotion/education
Mental Health 290134 290134 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ten minutes of brief physician counseling on smoking cessation. The counseling was administered face-to-face, on individual basis, stage-matched counseling, all participants were given information regarding the health benefits of smoking cessation and health hazards of continue smoking. Treatments modalities available to help quit smoking at the nearest quit smoking facilities were explained and contacts given.
Intervention code [1] 287596 0
Behaviour
Comparator / control treatment
No treatment
Control group
Active

Outcomes
Primary outcome [1] 290082 0
The translated and validated version of the Stages of Change Questionnaire Short Form in Malay version was used (with author's permission) to determine the stages of smoking behaviour at the beginning of the study, one month, and three months after the intervention, to determine any improvement in smoking behaviour.
Timepoint [1] 290082 0
One month and three months post intervention
Secondary outcome [1] 303909 0
NIL
Timepoint [1] 303909 0
NIL

Eligibility
Key inclusion criteria
Current smokers
Remained in the same workplace for more than three months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smokers who are actively engaging in smoking cessation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited at the factory clinic. Potential participants were given participant information sheet, and once they agreed, informed consent was taken. Allocation was concealed in sequentially numbered files.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomization was done using a table of random numbers generated from online calculator (Open EpiT calculator).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quit rate of 22% was used in the calculation as shown in similar study. A sample size of 148 was obtained with confidence interval of 95% and power of 80%. Estimating a drop out rate of 10%, the targeted sample size was 163. Chi-Square test was used to study the association between categorical variables (eg between stages of smoking behaviour and the control or intervention groups), missing data was included in no improvement as intention to treat, and p value of < 0.05 was taken as statistically significant

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/09/2012
Actual
3/09/2012
Date of last participant enrolment
Anticipated
24/09/2012
Actual
24/09/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
163
Accrual to date
Final
Recruitment outside Australia
Country [1] 5256 0
Malaysia
State/province [1] 5256 0
Selangor

Funding & Sponsors
Funding source category [1] 287713 0
University
Name [1] 287713 0
University of Malaya
Country [1] 287713 0
Malaysia
Primary sponsor type
University
Name
University of Malaya
Address
Lembah Pantai,
50603 Kuala Lumpur
Country
Malaysia
Secondary sponsor category [1] 286442 0
None
Name [1] 286442 0
Address [1] 286442 0
Country [1] 286442 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289669 0
University Malay Medical Centre Ethical Committee
Ethics committee address [1] 289669 0
Ethics committee country [1] 289669 0
Malaysia
Date submitted for ethics approval [1] 289669 0
29/11/2011
Approval date [1] 289669 0
18/01/2012
Ethics approval number [1] 289669 0
896.12

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41702 0
Dr Yung Wen Han
Address 41702 0
Department of Primary Care
University Malaya
Lembah Pantai
50603 Kuala Lumpur
Country 41702 0
Malaysia
Phone 41702 0
+60379492306
Fax 41702 0
Email 41702 0
[email protected]
Contact person for public queries
Name 41703 0
Yung Wen Han
Address 41703 0
Department of Primary Care
University Malaya
Lembah Pantai
50603 Kuala Lumpur
Country 41703 0
Malaysia
Phone 41703 0
+60379492306
Fax 41703 0
Email 41703 0
[email protected]
Contact person for scientific queries
Name 41704 0
Yung Wen Han
Address 41704 0
Department of Primary Care
University Malaya
Lembah Pantai
50603 Kuala Lumpur
Country 41704 0
Malaysia
Phone 41704 0
+60379492306
Fax 41704 0
Email 41704 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.